Safety and efficacy studies in drug evaluation—both in vitro and in vivo—are required prior to any experimental drug being administered to humans. The FDA will review all of these studies before it approves an Investigational New Drug (IND) application. No clinical trials can be conducted without an approved IND. Pre-clinical evaluations consist of both in vitro and in vivo studies. In vitro studies usually involve cell cultures or isolated organ systems while in vivo studies involve the administration of the drug to one or more animal species by one or more different routes of administration. These include oral, nasal, topical rectal, inhalation and by injection.
In Vitro Studies: These studies are conducted to ascertain the mechanism by which a drug is producing its pharmacological effect. The drug is administered to a specific tissue or organ which is excised from the animal.
In Vivo Studies: The drug is tested on animals to evaluate the pharmacokinetics (absorption, distribution, metabolism, and excretion of the drug). In addition, information regarding how quickly and efficiently the drug is absorbed is obtained. This includes calculating the maximal plasma concentration (Cmax) and the time the maximal concentration is achieved (Tmax). In vivo studies are conducted to determine dose-response relationships as well as to observe any minor side effects or significant adverse events.
Toxicology Studies: The goal of this step is to identify unanticipated adverse effects at normal doses and effects observed when the drug concentration exceeds the maximal effective dosing regimen.
Mesa Science Associates has been involved in conducting pre-clinical studies for over five decades. We can help generate experimental protocols, provide oversight of the experiments, help in the interpretation of the results and generate final reports.
